Meglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial

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dc.creatorDario Brock Ramalho
dc.creatorRosiana Estefane da Silva
dc.creatorHugo Silva Assis Moreira
dc.creatorDaniel Moreira de Avelar
dc.creatorAna Rabello
dc.creatorGlaucia Fernandes Cota
dc.creatorMaria Camilo Ribeiro de Senna
dc.creatorMariana Junqueira Pedras
dc.creatorLara Saraiva
dc.date.accessioned2024-11-28T20:56:02Z
dc.date.accessioned2025-09-08T22:54:02Z
dc.date.available2024-11-28T20:56:02Z
dc.date.issued2018
dc.format.mimetypepdf
dc.identifier.doi10.1590/0074-02760180200
dc.identifier.issn1678-8060
dc.identifier.urihttps://hdl.handle.net/1843/78354
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofMemórias do Instituto Oswaldo Cruz
dc.rightsAcesso Aberto
dc.subjectAntimoniato de Meglumina
dc.subjectLeishmaniose Cutânea
dc.subjectTerapia
dc.subjectEnsaio Clínico
dc.titleMeglumine antimoniate intralesional infiltration for localised cutaneous leishmaniasis: a single arm, open label, phase II clinical trial
dc.typeArtigo de periódico
local.citation.epage8
local.citation.issue9
local.citation.spage1
local.citation.volume113
local.description.resumoBACKGROUND: Cutaneous leishmaniasis (CL) is a world-wide health problem which currently lacks effective, affordable and easy to use therapy. Recently, the meglumine antimoniate (MA) intralesional infiltration was included among the acceptable therapies for New World leishmaniasis. While this approach is attractive, there is currently little evidence to support its use in Americas. OBJECTIVES:: The aim of this study was to provide information about effectiveness and safety of a standardised MA intralesional infiltration technique for the treatment of CL. METHODS: It is a single-arm phase II clinical trial conducted at a Brazilian referral centre. CL cases with parasitological confirmation presenting a maximum of three CL-compatible skin lesions were treated with weekly MA intralesional infiltration by using a validated technique, up to a maximum of eight infiltrations. RESULTS: A total of 53 patients (62 lesions) were included. Overall, patients received a median of seven infiltrations (IQR25-75% 5-8) over a median treatment period of 43 days (IQR25-75% 28-52 days). The definitive cure rate at D180 was 87% (95% CI:77-96%). The majority of adverse events were local, with mild or moderate intensity. Bacterial secondary infection of the lesion site was observed in 13% of the treated patients, beside two intensity-three adverse events (hypersensitivity reactions).
local.publisher.countryBrasil
local.publisher.departmentMEDICINA - FACULDADE DE MEDICINA
local.publisher.initialsUFMG
local.url.externahttps://www.scielo.br/j/mioc/a/qpp8pQz5RRPzfXmb4XVGdLq/?lang=en

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